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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000000891
Receipt No. R000001074
Scientific Title Prospective study of tansarterial embolization for hepatocellular carcinoma with Lipiodol added Lecithin.
Date of disclosure of the study information 2007/11/15
Last modified on 2007/11/14

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Basic information
Public title Prospective study of tansarterial embolization for hepatocellular carcinoma with Lipiodol added Lecithin.
Acronym Tansarterial embolization for hepatocellular carcinoma with Lipiodol added Lecithin.
Scientific Title Prospective study of tansarterial embolization for hepatocellular carcinoma with Lipiodol added Lecithin.
Scientific Title:Acronym Tansarterial embolization for hepatocellular carcinoma with Lipiodol added Lecithin.
Region
Japan

Condition
Condition hepatocellar carcinoma
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Our objectives are improvement in the treatment of the primary hepatocellular carcinoma and improvement of convalescence of transcatheter arterial embolization, in useing the emulsion which added the lecithin (surfactant in Lipiodol).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes curative effect,response rate,survival time, survival rate
Key secondary outcomes adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Lecithin Group:We use the emulsion which added the lecithin which is a surfactant in Lipiodol for transcatheter arterial embolization.
Interventions/Control_2 Non-Lecithin Group:We use the Lipiodol which didn't add the lecithin for transcatheter arterial embolization.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria 1:Histologically proven or clinically diagnosed hepatocellular carcinoma in primary lesion.
2:Age20-85
3:Performance Status0-1(ECOG)
4:Life expectancy at least 3 months.
5:Adequate organ and marrow function listed below.
a.White blood cell(WBC):3,000<=WBC<12,000/uL
b.Absolute neutrophil count(Neu):Neu >=1,800/uL
c.Hemoglobin(Hb): Hb>=8.0g/dL
d.Serum creatinine(Cr):W.N.L
e. Electrocardiogram(ECG):normal
6:Do not become the adaptation of resection,transplant,and local treatment in algorithm of HCC treatment.
7:Without contraindication of TAE.
8:The patient who have given written informed consent to participant in this study.
Key exclusion criteria 1:The patient with the anamnesis of the drug hypersensitivity.
2:The patient with contraindication of medication(Hydrochloric acid doxorubicin, Lipiodol, Gelpert and lecithin).
3:The patient with contraindication of TAE.
a.Severe liver failure
b.Serum Bilirubin(T-Bil):T-Bil>3mg/dl
c.Large quantities of acites.
4:The patient having the activity-related infectious disease(more than fever 38.0 degrees ).
5:The patient having the a serious complication.
6:Pregnant woman.
7: Patients who are judged inappropriate to be enrolled in this study by the doctor in charge.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masakazu Yamamoto
Organization Tokyo Women's Medical University
Division name Department of Surgery, Institute of Gastroenterology
Zip code
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-8111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shun-ichi Ariizumi, Yutaka Takahashi ,
Organization Tokyo Women's Medical University
Division name Department of Surgery, Institute of Gastroenterology
Zip code
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-8111
Homepage URL
Email yutaka@ige.twmu.ac.jp

Sponsor
Institute Women's Medical University
Institute
Department

Funding Source
Organization Women's Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization none

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2007 Year 11 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status
Date of protocol fixation
2007 Year 03 Month 17 Day
Date of IRB
Anticipated trial start date
2007 Year 04 Month 01 Day
Last follow-up date
2009 Year 12 Month 01 Day
Date of closure to data entry
2009 Year 12 Month 01 Day
Date trial data considered complete
2009 Year 12 Month 01 Day
Date analysis concluded
2009 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 11 Month 14 Day
Last modified on
2007 Year 11 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001074

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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